Certolizumab Pegol for the Treatment of Patients With Active RA - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00717236

Purpose

This study is designed to assess the clinical response rate as measured by the ACR20 response rate at Week 12 in patient with Rheumatoid Arthritis.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Certolizumab pegol Other: Saline	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Certolizumab pegol

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase IIIb, Multicenter Study With a 12-Week Double-Blind, Placebo-Controlled, Randomized Period Followed by an Open-Label, Extension Phase to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered to Patients With Active Rheumatoid Arthritis.

Further study details as provided by UCB:

Primary Outcome Measures:

To assess the clinical responses rate as measured by ACR20 response rate [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess for all patients at week 12: responder rate, disease activity, fatigue, physical functioning. In the group remaining in the study after week 12: responder rate, disease activity, fatigue, physical functioning. [ Time Frame: Week 12 and every 8 weeks therafter, until study completion ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CDP870: Experimental	Drug: Certolizumab pegol Liquid certolizumab pegol to be administered as 200 mg subcutaneous injection (200mg per syringe).
Placebo: Placebo Comparator	Other: Saline Saline to be administered as subcutaneous injections

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment. Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trials.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717236

Contacts

Contact: UCB Clinical Trial Call Center

1 877 822 9493

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	C87094, CPD870/C87094
Study First Received:	July 15, 2008
Last Updated:	April 17, 2009
ClinicalTrials.gov Identifier:	NCT00717236 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Ethics Review Committee

Keywords provided by UCB:

Certolizumab pegol
Cimzia
Rheumatoid Arthritis
Joint Disease
Chronic Arthritis

Study placed in the following topic categories:

Immunoglobulin Fab Fragments
Antibodies
Autoimmune Diseases
Immunologic Factors
Musculoskeletal Diseases
Arthritis

Joint Diseases
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Immunoglobulins

Additional relevant MeSH terms:

Immunoglobulin Fab Fragments
Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Physiological Effects of Drugs
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009